FDA calls for new regulation on CBD
The U.S. Food and Drug Administration (FDA) is open to developing a new regulatory framework for cannabidiol (CBD), according to an agency official speaking at RAPS Convergence 2023.
“FDA is committed to sound, science-based CBD policies,” said Owen McMaster, senior reviewer for pharmacology/toxicology in the Division of Pharmacology/Toxicology for Infectious Diseases (DPT-ID) in the Office of Infectious Diseases (OID) at FDA’s Center for Drug Evaluation and Research (CDER). “We look forward to working with Congress on a new path forward: a regulatory and harm reduction approach.”
Hundreds of new cannabis products
Interest in cannabis and cannabis sativa-related products has increased over the past decade. The FDA has received 50 investigational new drug (IND) applications for cannabis-related products over the past 800 years, including 400 IND applications in the past 10 years. The agency currently has 150 active INDs in the areas of addiction, pain, medicine, neurology, immunology and inflammation, McMaster told RASP.org.
CBD currently has an estimated market size of at least $4 billion. If the agency provides guidance on how to sell CBD safely, this figure is expected to increase faster than it does today. This requires good regulations.
McMaster explained that the FDA has received several petitions from citizens requesting that the agency allow CBD products to be regulated as dietary supplements. “Unfortunately, the existing regulatory frameworks we have for foods and supplements are not appropriate for cannabidiol. It is unclear how CBD products can meet the safety standards for dietary supplements or food additives,” he explained.
CBD Safety Standard
“In regulating drugs, the FDA uses a safety standard that considers risks and benefits for people with a specific medical condition, while dietary supplements are “used by a broader group” of people seeking to supplement diet and maintain health. The standard for foods and nutritional supplements is that the product has a reasonable expectation of safety. “Benefits are not taken into account.”
A working group tasked with examining studies on CBD-related products, such as Epidiolex, released a statement in January 2023 explaining the reasoning behind the conclusion that CBD could not meet safety standards for dietary supplements or food additives. Considerations included the lack of evidence on safe consumption levels of CBD and on the safe duration of consumption. The working group also found risks associated with the administration of CBD to animals and a potential risk of exposure for people consuming meat, milk, and eggs from animals to which CBD was administered.
“A new regulatory pathway needs to be developed. “A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks associated with CBD products.”
However, a Congressional mandate is needed before the FDA can begin its work in this area. In October 2022, the White House issued a statement asking the U.S. Secretary of Health and Human Services and the Attorney General to review how cannabis is regulated under federal law. A decision by the Drug Enforcement Agency is pending.
In the meantime, McMaster indicated that FDA is committed to enforcement efforts targeting high-risk drugs.
Source: rasp.org (EN)
The U.S. Food and Drug Administration (FDA) is considering the development of a new regulatory framework for cannabidiol (CBD), as stated by an FDA official speaking at RAPS Convergence 2023.
Owen McMaster, senior reviewer for pharmacology/toxicology in the Division of Pharmacology/Toxicology for Infectious Diseases (DPT-ID) at FDA’s Center for Drug Evaluation and Research (CDER), emphasized the FDA’s commitment to science-based CBD policies. He expressed the agency’s willingness to collaborate with Congress to establish a regulatory and harm reduction approach.
Hundreds of new cannabis products
Over the past decade, there has been a growing interest in cannabis and cannabis sativa-related products. The FDA has received 50 investigational new drug (IND) applications for cannabis-related products in the past 800 years, with 400 applications submitted within the last 10 years. Currently, the agency has 150 active INDs focusing on addiction, pain, medicine, neurology, immunology, and inflammation, McMaster informed RASP.org.
The CBD market is currently estimated to be worth at least $4 billion. If the FDA provides guidance on the safe sale of CBD, it is expected to further accelerate its growth. This necessitates the establishment of effective regulations.
McMaster explained that the FDA has received petitions from citizens advocating for the regulation of CBD products as dietary supplements. However, existing regulatory frameworks for foods and supplements are deemed inadequate for CBD. Ensuring that CBD products meet safety standards for dietary supplements or food additives remains unclear.
CBD Safety Standard
Regarding drug regulation, the FDA employs a safety standard that considers risks and benefits for individuals with specific medical conditions. Conversely, dietary supplements are used by a broader range of individuals seeking to supplement their diet and maintain health. The standard for food and nutritional supplements is based on a reasonable expectation of safety, with benefits not taken into account.
A working group, responsible for studying CBD-related products like Epidiolex, released a statement in January 2023 highlighting the reasons why CBD fails to meet safety standards for dietary supplements or food additives. These reasons include the lack of evidence on safe consumption levels and duration of CBD use. The working group also identified risks associated with administering CBD to animals and potential exposure risks for individuals consuming meat, milk, and eggs from CBD-treated animals.
“A new regulatory pathway must be developed to benefit consumers by implementing safeguards and oversight to manage and minimize risks associated with CBD products,” said McMaster.
However, the FDA requires a Congressional mandate before commencing work in this area. In October 2022, the White House issued a statement urging the U.S. Secretary of Health and Human Services and the Attorney General to review federal cannabis regulation. The Drug Enforcement Agency’s decision is pending.
Meanwhile, McMaster assured the public that the FDA remains dedicated to enforcing measures targeting high-risk drugs.
Source: rasp.org (EN)
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